UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Statin therapy for preeclampsia
Title of the study (Brief title)	Statin therapy for preeclampsia
Region	Japan

Condition
Condition	preeclampsia
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine whether statin inhibits oxidative stress in patients with preeclampsia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	maternal blood pressure, body weight, edema, liver function, kidney function, serum lipids, urinary protein
Key secondary outcomes	obstetric history, age, postpartum blood pressure, body weight, edema, liver function, kidney function, serum lipids, urinary protein until one week, extend the period of pregnancy, maternal serum soluble fms-like tyrosine kinase 1, maternal serum tumor necrosis factor alfa, maternal urine F2-Isoprostanes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	administration of statin Participants take pravastatin 10mg per day from diagnosis of preeclampsia to termination. If participants have severe hyperlipemia, they take pravastatin 20mg per day.
Interventions/Control_2	non-administration of statin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	55 years-old >=
Gender	Female
Key inclusion criteria	Patients who have preeclampsia with hyperlipemia.
Key exclusion criteria	Unconsented by patients or therapist cyclosporin therapy Past history of rhabdomyolysis Past history of allergic reaction for statins
Target sample size	50

Research contact person
Name of lead principal investigator	Eiji Kondoh
Organization	Kyoto University
Division name	Department of Gynecology and Obstetrics
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3269
Email	kondo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Shingo Io
Organization	Kyoto University
Division name	Department of Gynecology and Obstetrics
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3269
Homepage URL
Email	shinio@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Department of Gynecology and Obstetrics
Institute
Department

Funding Source
Organization	Kyoto University Department of Gynecology and Obstetrics
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	京都大学医学部附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 22 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 01 Month 22 Day
Anticipated trial start date	2016 Year 02 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 21 Day
Last modified on	2019 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023870